Active clinical trials for "Inflammation"

Cardiovascular diseases are the number 1 cause of death globally, taking an estimated 17.9 million lives each year (31% of deaths worldwide). Hypertension, with 1.13 billion people affected worldwide, is the leading risk factor for global mortality. Physical inactivity is among the modifiable cardiovascular risk factors. While the beneficial effects of physical activity on cardiovascular system are widely known, the mechanisms involved are not completely understood. Both exercise training and hypertension are linked to inflammation. Furthermore, there is evidence that gut microbiota regulates inflammatory patterns. Recent investigations showed a relationship between exercise training and the composition/functionality of the gut microbiota. Anyway, the modification of the composition and functionality of the gut microbiota in hypertension due to the exercise training and the relative involvement of oxidative stress and inflammation are not completely understood. In literature an association between gut microbiota composition and arterial stiffness is described, in particular, the investigators observed both a direct correlation between arterial stiffness and abundances of bacteria associated with altered gut permeability and inflammation; and an inverse relationship between arterial stiffness, microbiota diversity, and abundances of bacteria associated with most fit microbiota composition. Anyway, while these association were stable in animal studies, in human studies none of the identified interventional trials was able to demonstrate this relationship. Of note, only half of human studies measured BP, and very few adjusted the vascular analyses for BP variation, which is a major determinant of arterial stiffness. This is a non-profit, monocentric, non-pharmacological interventional study, a randomized controlled trial with three intervention arms, partial double-blind, aiming to verify the hypothesis that, in hypertensive patients in primary prevention with cardiovascular risk factors, physical exercise favorably modifies the intestinal bacterial flora compared to the probiotic, with a positive impact on cardiovascular health, and to demonstrate that this involves inflammation modulation. There will be 3 intervention arms, with 1:1:1 stratified randomization by gender: 1. Administration of controlled physical activity training; 2. Administration of probiotic; 3. Administration of placebo. Arms 2 and 3 will be double-blind. The intervention will last for three months, followed by a 6-month follow-up period. Afterwards, the medical team may be contacted for further tests/assessments or simply for information about the participant's health status, for a total duration of 24 months. The investigators hypothesize that hypertensive patients in cardiovascular primary prevention have a dysbiotic gut microbial signatures, that could be a new marker of early vascular aging. Secondly, the investigators anticipate that exercise training will modify both gut microbiota and hemodynamic profile, and that a relationship exists between gut microbiota and hemodynamic modifications. Thirdly, the investigators expect that the beneficial effects of exercise training are driven by positive changes in the inflammatory modulators.

Zinc is a pivotal micronutrient that participates in numerous essential metabolic pathways within the human body. Its multifaceted role makes the manifestations of zinc deficiency remarkably nonspecific and age-dependent. In children, zinc deficiency can manifest as growth retardation, cognitive impairment, recurrent infections, and other diverse symptoms. Adolescents and adults may experience fertility issues, work capacity impairment, and metabolic disorders due to zinc deficiency. Furthermore, zinc plays a crucial role in maintaining immune function, particularly in the elderly, where recurrent infections can be a notable outcome of deficiency. Given its fundamental importance, the potential benefits of zinc supplementation and fortification strategies have been explored, with some evidence indicating positive effects on health outcomes such as childhood mortality, diarrhea morbidity, and even risk factors for conditions like Type 2 Diabetes (T2DM) and cardiovascular disease (CVD). Understanding zinc's significance in these metabolic processes is vital for addressing deficiencies and improving public health. A study is needed to assess the effect of various types of fermented and unfermented wheat flour flatbread and its impact on health including zinc status, anthropometric outcomes, risk of T2DM and CVD and morbidity on adolescent and adult females. The whole wheat flatbread trial would be ideal to inform policy as it is regularly consumed in Sindh as most people rely on chakki for wheat grinding and it is used commonly to make roti at home.

Microvascular inflammation, the hallmark histological criteria of antibody-mediated rejection in kidney transplantation, remains an issue in routine practice, due to a lack of reproducibility in its recognition by pathologists and an incomplete comprehension of its pathophysiology, leading to a poor treatment efficacy. The main objective of this study is to assess the performances of tissue proteic signatures designed for the diagnosis of microvascular inflammation in kidney transplantation, from formalin-fixed and paraffin-embedded (FFPE) allograft biopsies analyzed by mass spectrometry-based proteomics.

A randomized, double-blind, crossover dietary intervention trial will test the effects of 4 weeks of daily honey-flavored yogurt intake on markers of inflammation (Th17 cytokines) and oxidative stress (NOX2, UA, RSNO) and associative changes with microbial derived metabolites (SCFAs, BAs, ellagitannins), metabolism and the fecal microbiome. The above suite of selected markers will capture diet-induced systemic changes in inflammation and oxidative stress, while assessing associated microbial changes.

This study is a randomized, placebo-controlled, double blinded pilot study to assess the effect of consuming plant sterol or plant stanol esters (3 grams/day) for 6 months on ALT concentrations in subjects with elevated ALT concentrations, i.e. who are at risk to develop NASH.

To study the effect of short-term zinc supplementation on improving inflammation, metabolic, and cardiovascular risk among HIV infected patients on stable anti-retroviral therapy

Cross-over double-blind study. Healthy subjects will be exposed to diesel exhaust fumes and/or filtered air during a 2-hour session. Several parameters will be assesed i.e. endothelial function will be assessed with flow mediated dilation (FMD) techniques, arterial stiffness with pulse wave velocity (PWV) and reflected waves with augmentation index (AIx). C reactive protein (CRP), fibrinogen, protein C levels and protein S activity will be also measured. Heart rate variability and standard deviation of normal to normal intervals R-R intervals (SDNN) will be used to assess sympathetic activity. Measurements were assessed before, 2 and 24 hours after diesel exposure.

The goal of this clinical trial is to explore the effect of Lactobacillus johnsonii and white pomegranate extract on female bacterial status, it aims to answer are: Evaluate Lactobacillus johnsonii TCI250 probiotics or white pomegranate extract in regulating female vaginal bacteria and improving vaginal health. Evaluate Lactobacillus johnsonii TCI250 probiotics or white pomegranate extract in regulating inflammation. Participants will be randomly assigned to placebo (n = 50), probiotic heat-killed Lactobacillus johnsonii TCI250 group (n = 50) and white pomegranate extract group (n = 50) for 8 weeks. Researchers will compare the vaginal flora and inflammation.

The goal of this clinical trial is to reduce inflammation and improve glycemic control in healthy volunteers, parents, as well as children, adolescents and adults with or without diabetes. The main questions it aims to answer are: • does a reduction wheat gluten improve glycemic control and/or inflammatory biomarkers • does a reduction in certain amino acids (which is most common in wheat gluten) improve glycemic control and/or inflammatory biomarkers • can we identify individuals with an inflammatory response, which leads to poor glycemic control. Participants will eat gluten-free products as well as similar products containing gluten. They will also eat gluten together with probiotics to see if an effect of gluten can be reduced. Researchers will compare everyone with themselves (cross-over design) and if possible individuals with and without diabetes.

Periodontal diseases are a public health burden in all countries. Hence, Periodontitis is the sixth-most prevalent disease in the world, the most common bone diseases in human and the primary cause for tooth loss in adults leading to significant economic and medical consequences. All disease biomarkers could help to stratify the general population with those at high risk of periodontitis and to enroll them in a rigorous prevention program. Advanced periodontitis has been shown to reduce the quality of life of patients and developing novel biological monitoring protocols will reduce the prevalence of advanced forms of the disease. There are alot of research explaining the different types of inflammatory mediators that could be found in periodontitis patients. But there are a few research have been talking about lipoxin A4 as an inflammatory biomarker that could detect the effect of non surgical periodontal therapy effect on the periodontal health. And the aim of the study is to assess the effect of this non surgical periodontal therapy on the periodontal health by assessing the concentration of this biomarker.